Lens storage and folding apparatus

ABSTRACT

An intraocular lens storage container includes a lens folding system for folding the lens and inserting it into a lens insertion device or other lens receiving chamber. The fold and insertion process requires no special training and results in the lens being positioned in a known orientation. Also, the possibility of damaging the lens is minimized.

This application claims benefit of provisional application 60/007,198,filed Nov. 1, 1995, and provisional application 60/007,697, filed Nov.29, 1995.

FIELD OF THE INVENTION

The present invention relates to storing and folding an intraocular lensprior to implantation.

BACKGROUND AND SUMMARY

An intraocular lens (IOL) is implanted in an eye of a patient to enhanceor restore vision. Many configurations of IOLs are known. The IOL andthe haptics, which hold the IOL in the eye, come in many forms. Untilrecently, the IOLs were generally inflexible and required an incisionapproximately equal in length to the diameter of the lens to beimplanted. For a number of medical and clinical reasons, however, thelength of the incision should be minimized.

Recently, foldable IOLs have been developed. Various configurations offoldable IOLs exist and the materials used to make them vary. Thefoldable IOL permits the incision for implantation to be smaller thanthat required for previous IOLs (e.g., fifty percent smaller or less).The inventors recognized the substantial benefits of using a smallerincision without jeopardizing the quality of the IOL.

Procedures have been developed for folding an IOL prior to implantation.These procedures generally involve using forceps to fold the IOL while asecond forceps holds the IOL, or the IOL is positioned on a mechanicaldevice and gripped by forceps. Variations on this procedure have beendeveloped by different ophthalmologists commensurate with theirparticular manual dexterity, surgical skills, and preference ofinstruments.

Tubular IOL insertion devices have been developed to assist theophthalmologist in inserting a foldable IOL into a patient's eye. TheIOL is folded manually as described above and loaded into the insertiondevice. The distal end of the insertion device is passed through anincision in the eye and the folded IOL is then pushed through the distalend and expelled from the insertion device into the capsulary bag of theeye. The IOL is then centered within the eye and held in place by thehaptics. In a limited number of cases, the IOL must be sutured into adesired position.

Various problems may arise while removing the IOL from its sterilestorage container, manually folding the IOL, manually placing the foldedIOL into the insertion device, and expelling the IOL into the eye. Theprofessional must not drop the IOL, or damage the IOL by improperlyfolding it. Next, the professional must properly insert the folded IOLinto the delivery device without damaging it. The IOL must be positionedin the insertion device in the proper orientation so that the IOL andassociated haptics are not damaged during the process of expelling theIOL into the eye.

At all times, the professional must maintain the sterility of the IOL.Once the sterility of the IOL is broken, it must be discarded.Additionally, the folding and inserting process can be time consuming.

In view of the above problems recognized by the inventors, it is anobject of the present invention to fold and insert an IOL into a lensdelivery device without damaging the IOL.

It is another object of the present invention to fold and insert an IOLinto a lens delivery device while maintaining the sterility of the IOL.

It is another object of the present invention to fold and insert an IOLinto a lens delivery device quickly and without the need for specialtraining or dexterity skills.

According to the present invention, a container that stores an IOL alsofunctions as an "automatic" IOL folding and inserting device. Thesterile IOL is positioned within the container. The container alsoincludes a lens folding mechanism. The container may be coupled with alens delivery device.

In one embodiment, the IOL is folded and inserted into a lens deliverydevice in a predetermined orientation during the coupling process. Inanother embodiment, after the lens delivery device is coupled with thecontainer, a manipulation of the container folds and inserts the IOLinto the lens delivery device in a predetermined orientation. In eitherembodiment, the sterility of the IOL is maintained, and the lens isfolded and inserted in a manner that minimizes the possibility ofdamaging the IOL.

The present invention provides a number of advantages. Transfer andfolding of the IOL is performed quickly and without the need forspecialized training or skills. The IOL is never "directly" handled by aperson (e.g., by forceps) minimizing the possibility of damaging thelens from mishandling, improper folding, or improper insertion into thelens delivery device. The IOL is always folded and positioned in thelens insertion device in a predetermined orientation.

Also, the sterility of the IOL is maintained. Finally, the lenscontainer serves the dual purpose of (1) storing the IOL, and (2)folding and inserting the IOL into the lens delivery device. Otheradvantages and features will become apparent from the followingdescription and claims.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1A is a plan view of a lens insertion device.

FIG. 1B is a cross-sectional view of a lens insertion device.

FIG. 1C is a plan view of another embodiment of a lens insertion device.

FIG. 2A is a perspective view of an embodiment of a lens storage andfolding apparatus.

FIG. 2B is a side view of an embodiment of a lens storage and foldingapparatus.

FIGS. 2C-2D are cross-sectional views of embodiments of a lens storageand folding apparatus.

FIG. 2E is a perspective view of an embodiment of a lens storage andfolding apparatus showing the lens folding system.

FIGS. 2F-2G are side views of a lens insertion device receiving a lensfrom an embodiment of a lens storage and folding apparatus.

FIG. 3 is a diagram of a four-bar mechanical linkage representative ofthe lens folding system of an embodiment of a lens storage and foldingapparatus.

FIGS. 4A-4B are perspective views of an embodiment of a lens storage andfolding apparatus.

FIG. 4C is perspective view of the second surface of an embodiment of alens storage and folding apparatus.

FIG. 4D is a cross-sectional view of an embodiment of a lens storage andfolding apparatus.

FIGS. 5A-5B are side views of a lens insertion device receiving a lensfrom an embodiment of a lens storage and folding apparatus.

FIG. 6 is a perspective view of an embodiment of a lens storage andfolding apparatus.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIGS. 1A-1B show an IOL insertion device 10 used to insert an IOL 12into a patient's eye. Insertion device 10 includes sleeve 14, nozzle 16,and mating tab 17. Nozzle 16 may be a separate component removablyconnected with sleeve 14, or a tapered extension of sleeve 14. Sleeve 14includes a lens receiving slot 18 for receiving an IOL 12. IOL 12 isfolded inside sleeve 14. IOL 12 is folded roughly in half along thelongitudinal axis of sleeve 14 (shown by dashed line A) so that the twohalves of the concave surface of IOL 12 generally face each other, asshown in FIG. 1B.

FIG. 1C shows another embodiment of an insertion device 10. A removablecartridge 15 is positioned in sleeve 14. Removable cartridge includes alens receiving slot 18 for receiving an IOL 12. In another embodiment,all or a distal part of sleeve 14 may be disposable.

IOL insertion device 10 also includes a retractable lens piston 20controlled by an actuator 21. In one embodiment, actuator 21 is a motor.In another embodiment, piston 20 may include an extension which allowsthe surgeon to control the movement of piston 20 manually. When nozzle16 is properly positioned in a patient's eye through an incision, piston20 moves along longitudinal axis A of sleeve 14, pushing IOL 12 throughnozzle 16 until IOL 12 is expelled into the eye. Piston 20 is thenretracted toward the proximal end 22 of sleeve 14.

Piston 20 may have a rounded lens-contacting tip 24 as shown in FIG. 1A,or other appropriate shape (e.g., flat or ballooned) to push IOL 12 intothe patient's eye without damaging IOL 12. Tip 24 may also include agroove for receiving the haptics so that the haptics are not damagedduring the insertion process. One example of an IOL insertion device 10is disclosed in co-pending application Ser. No. 08/275,835, incorporatedherein by reference to the extent necessary for an understanding of thepresent invention.

IOL 12 is transferred from a storage container into sleeve 14. AlthoughIOL 12 is foldable (as shown in FIGS. 1A-1B), it should be handledcarefully throughout the transfer process to avoid even the slightestdamage, which may degrade the performance of IOL 12. IOL 12 is a sterileimplant and cannot be dropped or otherwise mishandled in a way thatcompromises its sterility. IOL 12 must be carefully folded so as toavoid tearing, permanent deformation, or microfractures. Tearing andpermanent deformation obviously can degrade the performance of IOL 12.Microfractures can also degrade the optical performance of IOL 12 andare difficult to detect by the IOL implantation team.

Failure to position IOL 12 in sleeve 14 through slot 18 in the properorientation may cause IOL 12 to bind or jam when being pushed throughnozzle 16. Such an incident may not only damage IOL 12 or the associatedhaptics, but also prevent the reuse of sleeve 14 and damage actuator 21or piston 20.

The present invention is directed to a dual-purpose IOL storagecontainer. The container stores the IOL in a sterile environment frompackaging until the IOL is to be implanted. The container also functionsas a sterile, "no-touch" lens folding system. The IOL is folded andtransferred to an IOL insertion device 10 automatically and in apredetermined orientation, while maintaining the sterility of IOL 12.

One embodiment of a lens storage and folding container is shown in FIGS.2A-2G. A housing 30 includes opposed first and second surfaces 32, 34,connected by opposed support surfaces 36, 38 and 40, 42, respectively,defining an enclosed storage chamber 44. Housing 30 is made of medicalgrade plastic or other material suitable for storing a sterile implant.

Support surface 40 includes an inner wall 45 which defines an aperture46. Aperture 46 has a width and height suitable for receiving nozzle 16and sleeve 14 of IOL insertion device 10. Aperture 46 may be covered bya tear-away panel 48 (shown in dotted line). In another embodiment,panel 48 may be permanently affixed to support surface 40, coveringaperture 46, and made of a thin-film material. Nozzle 16 is then used topuncture panel 48 as insertion device 10 is inserted into chamber 44.

FIG. 2B is a side view of chamber 44. A lens platform 50 is positionedin chamber 44. Lens platform 50 supports IOL 12 during storage. In oneembodiment, lens platform 50 extends from support surface 40, generallyparallel to first and second surfaces 32, 34. Lens platform 50 may beconnected to surface 40 by a cantilever mounting. In other embodiments,lens platform 50 may be suspended from first surface 32, supported bylegs extending from second surface 34, supported by support surfaces 36,38, or a combination thereof.

FIG. 2C shows lens platform 50 including an inner wall 51, which definesa lens folding aperture 52. A V-shaped groove 53 in wall 51 supports theperiphery of IOL 12, while a central portion of IOL 12 is suspendedacross aperture 52. Lens platform 50 may be made of any materialsuitable for supporting a sterile implant. IOL 12 is positioned ingroove 53 with haptics oriented so that when IOL 12 is folded, thehaptics will be in a desired position for insertion into sleeve 14.

In another embodiment, shown in FIG. 2D, mold 54 is positioned betweenlens platform 50 and second surface 34. Mold 54 defines a longitudinalchannel 56 extending from aperture 46 at support surface 40 to supportsurface 42 for receiving sleeve 14. Additionally, mold 54 definesinwardly-sloped, opposed upper surfaces 60, which generally define afunnel shape. Mold 54 may be removably positioned in chamber 44 orintegrally formed with housing 30.

Lens folding system 62 is also positioned in chamber 44. Lens foldingsystem 62 includes a support bar 64 which extends from support surface36 to support surface 38. In other embodiments, support bar 64 ispositioned by arms extending from first surface 32, second surface 34,or both. The ends 66 of support bar 64 slidably fit in opposed grooves68 on support surfaces 36, 38, allowing support bar 64 to rotate asshown by arrow B and move vertically (shown by arrow C) as allowed bygrooves 68.

An L-shaped lens folding member 70 is connected to support bar 64. Lensfolding member 70 includes a folding segment 72 having a lens foldingtip 74, and an actuating segment 76 positioned at a right angle tofolding segment 72. Lens folding member 70 is positioned on support bar64 within chamber 44 so that folding segment 72 is positioned duringstorage between platform 50 and first surface 32, and actuating segment76 extends from support bar 64 toward second surface 34. Also, lensfolding tip 74 is positioned between IOL 12 on platform 50 and firstsurface 32.

In one embodiment, support bar 64 is biased in grooves 68 toward firstsurface 32, e.g., by spring members 69A positioned in grooves 68.Additionally, one or more torsional springs 69B may be connected withsupport bar 64 to bias folding segment 72 between platform 50 and firstsurface 32.

FIGS. 2F and 2G show the process of folding and inserting IOL 12 intosleeve 14. Nozzle 16 is inserted into chamber 44 through aperture 46,and extended toward wall 42. Sleeve 14 is oriented relative to housing30 so that tab 17 is aligned to meet actuating segment 76. Tab 17catches actuating segment 76, overcoming the spring bias against supportbar 64, and initially moving support bar 64 in groove 68 toward secondsurface 34. The movement of support bar 64 causes lens folding tip 74 tomove along the path shown by line D. Lens folding tip 74 contacts thecentral portion of IOL 12, causing IOL 12 to fold through aperture 52,then through slot 18 into sleeve 14. The slope of walls 60 assistfolding IOL 12 in the embodiment of FIG. 2D. In either embodiment, IOL12 is folded in a predetermined orientation without excessive stress,thereby preventing tearing, permanent deformation, or microfractures.

Once IOL 12 is folded and positioned in sleeve 14, sleeve 14 is thendrawn back out of chamber 44 through aperture 46 in a reciprocal motion.As sleeve 14 exits aperture 46, folding segment 72 is forced out of slot18 and back toward its storage position above aperture 52 by torsionalspring 69B. Actuating segment 76 moves back toward its storage position,and the spring bias moves support bar 64 toward first surface 32.

FIG. 3 shows a diagram of a four-bar mechanical linkage which isrepresentative of lens folding system 62. Link L1 provides the groundfor the four-bar linkage circuit. Link L2, represented as having aninfinite length, corresponds to support bar 64 movable in grooves 68.Link L3 corresponds to folding and actuating segments 72, 76,respectively, of folding member 70. Link L4, also represented as havingan infinite length, corresponds to mating tab 17 acting on actuatingsegment 76. The configuration of lens folding system 62 is commonlyknown as a double-slider mechanism.

When a force, such as tab 17, acts on actuating segment 76, support bar64 initially moves towards second surface 34 causing folding segment 72,and more specifically folding tip 74, to move on a generally linearpath, shown by arrow D in FIG. 2F. The four-bar linkage provides anefficient way to use the energy of inserting nozzle 16 and sleeve 14into chamber 44 to actuate lens folding tip 74, folding IOL 12 throughaperture 52 and into sleeve 14. IOL 12 is automatically inserted intosleeve 14 in a known position by precisely timed movement of thefour-bar linkage. IOL 12 is positioned in sleeve 14 without damage. Thearrangement minimizes the need for any special training or skills by theperson loading IOL 12. The sterility of IOL 12 is also maintained.

FIGS. 4A-4D show another embodiment of a lens storage and foldingcontainer. A housing 100 includes a first surface 102 and opposed secondsurface 103. Opposed side surfaces 104, 106 connect first surface 102with second surface 103. Opposed side surfaces 108, 110 connect withsecond surface 103 and extend to the edges of first surface 102, but donot connect with first surface 102 or side surface 106. The combinationdefines a storage chamber 112.

First surface 102 includes hinge 114 extending from edge 116 of firstsurface 102 adjacent the top of side surface 108 to edge 118 of firstsurface 102 adjacent the top of side surface 110. Hinge 114 dividesfirst surface 102 into first and second planar members 120, 122,respectively. Second planar member 122 includes a generally U-shapedcutout, defining a lens folding tab 124 which extends from first planarmember 120 at hinge 114. Hinge 114 may be a flexure line dividing firstsurface 102.

First surface 102 and side surface 106 are not connected with sidesurfaces 108, 110. Therefore, three additional hinges are defined. Hinge125 is formed by the connection of the adjacent edges of second planarmember 122 and side surface 104. Hinge 126 is formed by the connectionof the adjacent edges of first planar member 120 and side surface 106.Hinge 127 is formed by the connection of the adjacent edges of sidesurface 106 and second surface 103. The combination of hinges 114, 125,126, 127 form a four-bar linkage.

In another embodiment, shown in FIG. 4B, leverage tab 128 extends fromhousing 100 adjacent hinge 125.

FIGS. 4A-4C show sleeve-receiving channel 132 extending along secondsurface 103 from side surface 104 to side surface 106. Sleeve-receivingchannel 132 is semi-circular and has a diameter slightly larger than thediameter of sleeve 14 to provide a stable coupling with sleeve 14.Sleeve-receiving channel 132 includes a tab receiving slot 134 forreceiving tab 17 of a lens insertion device 10. Tab 17 is positioned onsleeve 14 so that when tab 17 is positioned in tab receiving slot 134,lens transfer slot 136 aligns with lens receiving slot 18. Therefore,the coupling of sleeve 14 with housing 100 defines a precise orientationof sleeve 14 relative to housing 100 for the folding and transfer of IOL12 into sleeve 12.

In another embodiment, clamps or other locking devices may be used tocouple lens insertion device 10 with channel 132.

FIG. 4D shows lens platform 140 positioned in chamber 112 for supportingIOL 12 as described above regarding the embodiments of FIGS. 2A-2G. Onceagain, platform 140 may be anchored by a cantilever mount, suspendedfrom first surface 102 or supported from second surface 103 (as shown).Platform 140 includes an inner wall 141 which defines an aperture 142.IOL 12 is held in place by a V-shaped groove 144 in wall 141 and extendsacross aperture 142. In one embodiment, opposed tapered surfaces 146extend from lens platform 140 to lens transfer slot 136, serving to foldIOL 12 in the appropriate orientation without excessive stress on IOL12.

FIGS. 5A-5B show the lens storage and folding container of FIGS. 4A-4Din operation. Housing 100 is coupled with lens insertion device 10 andthe housing surfaces 102, 103, 104, and 106 form a four-bar linkage andfunction as a lens folding system. The ground or first link correspondsto second surface 103 and side surface 104. Side surface 106 correspondsto the second link. First member 120 and lens folding tab 124 correspondto the third link. Finally, second planar member 122 corresponds to thefourth link.

To actuate the four-bar linkage for folding IOL 12 into sleeve 14, auser can depress either first member 120 or second member 122 towardsecond plate 103, or move leverage bar 128 in the direction of arrow G(for the embodiment of FIG. 4B). First surface 102 flexes at hinge 114,driving the adjacent ends of first and second members 120, 122, towardsecond surface 103. Second member 122 flexes as hinge 125, and sidesurface 106 flexes at hinge 127. The movement of first member 120 causestip 150 of lens folding tab 124 to move along path E.

Path E is generally linear as tip 150 moves through aperture 142,folding and pushing IOL 12 through lens transfer slot 136, through slot18, and into sleeve 14. It should be noted that hinge 126 may remaingenerally fixed, defining about a ninety degree angle between firstmember 120 and support surface 106, which provides a simplified four-barlinkage. Therefore, hinge 126 may not be necessary, simplifying theconstruction of housing 100.

Using the lens storage and folding container of FIGS. 4A-4D requires nospecial training. The linkage lengths, passageway shapes, tab lengthsare all selected to define a precise orientation in order to fold IOL 12into sleeve 14 without tearing, permanently deforming, or fracturing IOL12.

Once the folded IOL 12 is seated within sleeve 14, the user releasesfirst or second member 120, 122, or leverage bar 128, allowing tab 124to return along linkage path E, exiting sleeve 14 through slot 18.Housing 100 can then be removed from sleeve 14, and IOL 12 is properlypositioned within sleeve 14 for insertion into the patient's eye.

In another embodiment, shown in FIG. 6, first surface 102 and sidesurface 106 are connected with side surfaces 108, 110 by breakable tabs160. During storage, breakable tabs 160 provide rigidity to housing 100and reduce the likelihood that the folding mechanism of housing 100 willbe accidentally actuated. Tabs 160 are designed so that the forcerequired to break the tabs is large enough to minimize accidentalactuation, but not so large as to result in uncontrolled actuation thatcould damage the IOL.

In another embodiment, first surface 102 is made of a deformablematerial. This eliminates the need for the several hinges in theembodiment described above. Lens folding tab 124 is actuated by placingpressure on the first surface 102 adjacent lens folding tab 124.

In the embodiments discussed above, the lens storage and folding deviceis described as docking with sleeve 14. In other embodiments, the lensstorage and folding device may dock also with removable cartridge 15 ora disposable sleeve 14. In the first instance, IOL 12 is loaded intocartridge 15, and cartridge 15 is loaded into lens insertion device 10.In the second instance, IOL 12 is loaded into disposable sleeve 14, anddisposable sleeve 14 is coupled with the remaining portions of lensinsertion device 10.

Other embodiments are within the scope of the following claims.

What is claimed is:
 1. A lens storage and folding apparatus,comprising:a housing having first and second generally opposed surfaces,support surfaces connecting at least a portion of the first and secondsurfaces, which define a cavity; and a lens-holding platform positionedin the cavity and connected with at least one of the surfaces; whereinat least the first surface is movable and comprises a lens foldingsystem; wherein the support surfaces comprise a first pair of generallyopposed side surfaces connected with the first and second surfaces, anda second pair of generally opposed side surfaces connected with thesecond surface; and wherein the first surface includes a first hingedividing the first surface into first and second members.
 2. Theapparatus of claim 1 wherein the platform includes an inner walldefining a lens aperture.
 3. The apparatus of claim 2 wherein the innerwall includes a groove.
 4. The apparatus of claim 1 further comprising asecond hinge connecting the second member with the first side surface ofthe first pair of opposed side surfaces, and a third hinge connectingthe second surface with the second side surface of the first pair ofopposed side surfaces.
 5. The apparatus of claim 4 wherein the secondhinge connects an edge of the second member with an edge of the firstside surface of the first pair of opposed side surfaces, and the thirdhinge connects an edge of the second surface with an edge of the secondside surface of the first pair of opposed side surfaces.
 6. Theapparatus of claim 4 further comprising a fourth hinge connecting thefirst member with the second side surface of the first pair of opposedside surfaces.
 7. The apparatus of claim 1 comprising a leverage barextending from one of the support surfaces.
 8. A lens storage andfolding apparatus, comprising:a housing having first and secondgenerally opposed surfaces, support surfaces connecting at least aportion of the first and second surfaces, which define a cavity; and alens-holding platform positioned in the cavity and connected with atleast one of the surfaces; wherein at least the first surface is movableand comprises a lens folding system; and wherein the second surfaceincludes a channel extending between generally opposed support surfaces.9. The apparatus of claim 2 further comprising a lens transfer slotpositioned on one of the surfaces, the lens transfer slot beinggenerally aligned with the lens aperture.
 10. The apparatus of claim 9further comprising a lens insertion device removably coupled with thetransfer-slot surface.
 11. The apparatus of claim 10 further comprisinga lens receiving slot, the lens receiving slot being aligned with thelens transfer slot when the lens receiving device is coupled with thelens-transfer surface.
 12. The apparatus of claim 1 further comprising alens folding tab extending from the first member adjacent the firsthinge.
 13. The apparatus of claim 12 further comprising breakable tabsconnecting the second pair of side surfaces with the first surface. 14.The apparatus of claim 12 further comprising breakable tabs connectingthe second pair of side surfaces with at least one of the first pair ofside surfaces.